Trial Outcomes & Findings for Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults (NCT NCT01685372)
NCT ID: NCT01685372
Last Updated: 2018-01-23
Results Overview
Gathered data on influenza and influenza-like-illness during the influenza season for which the subject was vaccinated. Reported numbers of episodes of PCR-diagnosed influenza and rates of reported Influenza-Like-Illness (ILI) from Questionnaire #2 and also that were obtained from medical records. Data were categorized by the following: 1. Polymerase chain reaction (PCR)-proven diagnosis of influenza performed at Children's Hospital Colorado (CHC) 2. Diagnosis of influenza by non-PCR rapid-influenza test 3. Diagnosis of ILI (from questionnaire #2). \[Centers for Disease Control (CDC) definition of ILI: Fever ≥ 100°F AND cough or sore throat in the absence of another known cause other than influenza for the illness.\]
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
up to 10 months after vaccination
Results posted on
2018-01-23
Participant Flow
Study subjects were recruited over two influenza seasons, 2013-2014 and 2014-2015. Subjects were recruited from the Dialysis unit and Rheumatology clinic in 2013-2014 by referral from clinicians. Subjects were recruited by mailed letter to Solid Organ Transplant recipients in 2014-2015.
In 2013-2014, 4 subjects chose not to enroll after learning more about the study. In 2014-2015, 2 subjects chose not to enroll after learning about the study. All potential subjects met pre-screening criteria. No subjects were excluded from the study by study personnel.
Participant milestones
| Measure |
Fluzone High Dose
A single-dose of high-dose influenza vaccine was administered to subjects randomized to this arm at T1
|
Fluzone Standard Dose
A single-dose of standard-dose influenza vaccine was administered to subjects randomized to this arm at T1
|
|---|---|---|
|
Timepoint 1 (T1): Vaccine,1st Blood Draw
STARTED
|
7
|
9
|
|
Timepoint 1 (T1): Vaccine,1st Blood Draw
COMPLETED
|
7
|
9
|
|
Timepoint 1 (T1): Vaccine,1st Blood Draw
NOT COMPLETED
|
0
|
0
|
|
Timepoint 2 (T2): 2nd Blood Draw
STARTED
|
7
|
9
|
|
Timepoint 2 (T2): 2nd Blood Draw
COMPLETED
|
7
|
9
|
|
Timepoint 2 (T2): 2nd Blood Draw
NOT COMPLETED
|
0
|
0
|
|
Timepoint 3 (T3): 3rd Blood Draw
STARTED
|
7
|
9
|
|
Timepoint 3 (T3): 3rd Blood Draw
COMPLETED
|
4
|
5
|
|
Timepoint 3 (T3): 3rd Blood Draw
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Fluzone High Dose
A single-dose of high-dose influenza vaccine was administered to subjects randomized to this arm at T1
|
Fluzone Standard Dose
A single-dose of standard-dose influenza vaccine was administered to subjects randomized to this arm at T1
|
|---|---|---|
|
Timepoint 3 (T3): 3rd Blood Draw
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults
Baseline characteristics by cohort
| Measure |
Fluzone High Dose
n=7 Participants
Fluzone High Dose 0.5 mL intramuscularly (IM) given once
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
|
Fluzone Standard Dose
n=9 Participants
Fluzone 0.5mL IM given once
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15 years
n=5 Participants
|
15 years
n=7 Participants
|
15 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Cohort
Dialysis
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cohort
Solid organ transplant
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Cohort
Rheumatoloty
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 10 months after vaccinationPopulation: Row 1: Number of influenza episodes diagnosed by PCR Row 2: Number of influenza episodes diagnosed by non-PCR rapid test Row 3: Number of influenza-like-illness (ILI) episodes reported by participants from the time of vaccination through June of the following year (end of flu season).
Gathered data on influenza and influenza-like-illness during the influenza season for which the subject was vaccinated. Reported numbers of episodes of PCR-diagnosed influenza and rates of reported Influenza-Like-Illness (ILI) from Questionnaire #2 and also that were obtained from medical records. Data were categorized by the following: 1. Polymerase chain reaction (PCR)-proven diagnosis of influenza performed at Children's Hospital Colorado (CHC) 2. Diagnosis of influenza by non-PCR rapid-influenza test 3. Diagnosis of ILI (from questionnaire #2). \[Centers for Disease Control (CDC) definition of ILI: Fever ≥ 100°F AND cough or sore throat in the absence of another known cause other than influenza for the illness.\]
Outcome measures
| Measure |
Fluzone High Dose
n=7 Participants
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
|
Fluzone Standard Dose
n=9 Participants
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
|
|---|---|---|
|
Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups
Row 1: Number of Influenza diagnosed by PCR
|
1 episodes of illness
|
1 episodes of illness
|
|
Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups
Row 3: Number of Influenza-like-illness
|
2 episodes of illness
|
8 episodes of illness
|
|
Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups
Row 2: # of Influenza diagnosis by non-PCR test
|
0 episodes of illness
|
0 episodes of illness
|
PRIMARY outcome
Timeframe: blood draw at 10-45 days post-vaccinationPopulation: All participants had blood drawn before vaccination and at timepoint 2. The influenza vaccine had the same subtypes during the two season. Data were analyzed for the 3 subtypes contained in the trivalent vaccine, H1N1, H3N2, B (Yamagata).
Measure hemagglutinin inhibition (HAI) on blood samples #2 for all subjects, which is the sample drawn at the "peak" of the immune response. Compare number of subjects who are seroprotected (reaching HAI ≥ 1:40) between the high-dose and standard-dose recipients..
Outcome measures
| Measure |
Fluzone High Dose
n=7 Participants
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
|
Fluzone Standard Dose
n=9 Participants
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
|
|---|---|---|
|
Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups
H1N1
|
7 Participants
|
7 Participants
|
|
Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups
H3N2
|
7 Participants
|
9 Participants
|
|
Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups
B (Yamagata)
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 0-14 days after vaccinationPopulation: All adverse events that may have been related are included in this analysis. Events considered not-related were excluded. More information on these AEs is included in the Adverse Events section. All AEs were reviewed by the study DSMB.
Number of adverse events reported within the 14 days after vaccination by each subject within each patient group. Data collected from that reported in safety questionnaires and in Safety Diary that spanned the 14 days post-vaccination.
Outcome measures
| Measure |
Fluzone High Dose
n=7 Participants
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
|
Fluzone Standard Dose
n=9 Participants
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
|
|---|---|---|
|
Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination
Local site reaction - grade 1
|
7 number of AEs reported
|
8 number of AEs reported
|
|
Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination
Local site reaction - grade 2
|
1 number of AEs reported
|
0 number of AEs reported
|
|
Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination
Other AEs - Grade 1
|
2 number of AEs reported
|
1 number of AEs reported
|
SECONDARY outcome
Timeframe: 10-45 days post-vaccinationPopulation: All participants had blood drawn at baseline (T1) and 10-45 days after vaccination (T2). Analysis was done for the 3 influenza subtypes in the trivalent influenza vaccine. The influenza vaccine was the same in 2013-2014 and 2014-2015.
HAI was measured on blood samples #1 and #2 for all subjects. Seroconversion is defined as a four-fold increase in antibody level between the high-dose and standard-dose recipients within each patient group was performed.
Outcome measures
| Measure |
Fluzone High Dose
n=7 Participants
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
|
Fluzone Standard Dose
n=9 Participants
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
|
|---|---|---|
|
Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups
H1N1
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups
H3N2
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups
B (Yamagata)
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: at least 5 months post vaccinationPopulation: Number of subjects seroprotected at T3 for each of the vaccine subtypes. 3 subjects in the HD group and 4 subjects in the SD group were lost-to-follow-up by T3 and not included in this analysis.
Measure HAI on blood sample #3, drawn May-September following vaccination. Report number who still have HAI ≥ 1:40 in the high-dose and standard-dose groups.
Outcome measures
| Measure |
Fluzone High Dose
n=4 Participants
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
|
Fluzone Standard Dose
n=5 Participants
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
|
|---|---|---|
|
Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups
H1N1
|
4 Participants
|
4 Participants
|
|
Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups
H3N2
|
4 Participants
|
5 Participants
|
|
Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups
B (Yamagata)
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: up to 9 months post-vaccinationPopulation: One subject in the high-dose group was originally on dialysis, but received a kidney transplant during the follow-up period. This subject was excluded from the analysis on change in baseline medical condition.
Evaluate disease status changes reported by subject on Questionnaire #2 as well as changes reported in clinic notes over the course of the influenza season. Subjects considered "worse" had worsening function of transplanted organ or complications related to underlying condition (e.g. dialysis) or new diagnosis of disease considered serious by PI.
Outcome measures
| Measure |
Fluzone High Dose
n=6 Participants
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
|
Fluzone Standard Dose
n=9 Participants
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
|
|---|---|---|
|
Change in Disease Status From Vaccination Through June of the Following Year
Same or better
|
5 Participants
|
9 Participants
|
|
Change in Disease Status From Vaccination Through June of the Following Year
Worse
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: (1) Date of vaccine through day 30 post-vaccine; (2) Day 31 post-vaccine through September 30 of the year following vaccinePopulation: Data used included: active reporting through day 30, survey at end of season, and chart review for data through Sept 30 of the year following vaccination.
Data gathered from the following 1. Safety data in 1st 14 days (safety surveys and safety diary) 2. Safety survey at day 30-45 regarding any unplanned health care visit or other AE during the 30 days after vaccine 3. On-going passive surveillance of adverse events (AEs)/serious adverse events (SAEs) throughout course of influenza season of enrollment 4. Chart review of each participant by PI through Sept 30 of the year following vaccine Data collection stopped in September following enrollment.
Outcome measures
| Measure |
Fluzone High Dose
n=7 Participants
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
|
Fluzone Standard Dose
n=9 Participants
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
|
|---|---|---|
|
Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination.
Day 0 (vaccination) through day 30
|
10 number of AEs reported
|
9 number of AEs reported
|
|
Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination.
Day 31 post-vaccination, through Sept 30
|
0 number of AEs reported
|
0 number of AEs reported
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10-45 days post-vaccinationThis secondary objective was included as exploratory and we plan to add additional analyses when funding is secured. There is no anticipated date when we will have this completed. (No immunogenicity studies have been done besides HAI.) For other immunogenicity: would compare results of blood draw #1 and #2 between the high-dose and standard-dose recipients for each patient group for any of the following: antibody avidity, microneutralization, T-cell interferon, T-cell IL-2, B-cell Immunoglobulin G (IgG) and B-cell Immunoglobulin A (IgA).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: (1) T2 measured 14-45 days post-vaccination; (2) T3 measured June 1-Sept 30 post-vaccination (end-of season), following vaccinationPopulation: For T3, only 4 participants in the high-dose group and 5 participants in the standard-dose group were analyzed due to loss-to-follow-up.
Seroprotection (HAI\>=1:40) and seroconversion (4-fold increase) together have been found to be a better predictor of vaccine effectiveness. Patients had to have both a 4-fold rise in HAI and have HAI\>=40 to be counted
Outcome measures
| Measure |
Fluzone High Dose
n=7 Participants
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
|
Fluzone Standard Dose
n=9 Participants
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
|
|---|---|---|
|
Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination
T3 - H1N1
|
1 Participants
|
0 Participants
|
|
Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination
T3 - H3N2
|
0 Participants
|
1 Participants
|
|
Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination
T3 - B (Yamagata)
|
1 Participants
|
0 Participants
|
|
Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination
T2 - H1N1
|
3 Participants
|
1 Participants
|
|
Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination
T2 - H3N2
|
5 Participants
|
5 Participants
|
|
Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination
T2 - B (Yamagata)
|
3 Participants
|
3 Participants
|
Adverse Events
Fluzone High Dose
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Fluzone Standard Dose
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluzone High Dose
n=7 participants at risk
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
|
Fluzone Standard Dose
n=9 participants at risk
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
|
|---|---|---|
|
Infections and infestations
Bacteremia
|
0.00%
0/7 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
11.1%
1/9 • Number of events 1 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
0.00%
0/9 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
Other adverse events
| Measure |
Fluzone High Dose
n=7 participants at risk
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
|
Fluzone Standard Dose
n=9 participants at risk
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
|
|---|---|---|
|
General disorders
Injection site reaction - pain
|
85.7%
6/7 • Number of events 6 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
77.8%
7/9 • Number of events 7 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction - induration
|
14.3%
1/7 • Number of events 1 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
0.00%
0/9 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction - bruising
|
14.3%
1/7 • Number of events 1 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
0.00%
0/9 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
|
General disorders
Fatigue
|
0.00%
0/7 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
11.1%
1/9 • Number of events 1 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
0.00%
0/9 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
0.00%
0/9 • AE data were collected from the date of vaccination (T1) through September 30 of the following year. AE data were collected differently over the study. At day 2-7 after vaccination, subjects were called to ask about AEs. Subjects were given a "Diary" to fill out for day 0-14 after vaccination, and the Diary was collected at T2. At day 30-45, subjects were given a questionnaire (in-person at T2 visit or by phone) asking about AEs and any unplanned medical visits during day 0-30 post-vaccine.
In May-June after vaccination, another questionnaire was collected by phone asking about influenza and influenza-like-illness, new health conditions, changes to underlying medical condition, or new immunosuppressive treatments since enrollment. Passive AE data were collected by providing participants with contact information for the study in order to report any concerns.
|
Additional Information
Donna Curtis, MD, MPH
University of Colorado School of Medicine
Phone: 720-777-6981
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place